Pfizer presented detailed results Friday at the Congress of ECCO showing that its JAK inhibitor tofacitinib met the primary and key secondary endpoints of the previously announced Phase III OCTAVE programme in ulcerative colitis. Study investigator Geert D'Haens said "we are encouraged by the results from the OCTAVE Induction studies, as they showed that in these trials oral tofacitinib reduced the symptoms of moderate-to-severe ulcerative colitis and induced remission of the disease," noting the results were "seen in patients who were previously treated with tumour necrosis factor inhibitors (TNFis), as well as those who had not received treatment with TNFis, and improvements in symptoms were observed as early as week two."
In the studies, adults with moderately to severely active ulcerative colitis were randomised to treatment with placebo or twice-daily oral tofacitinib. In OCTAVE Induction 1, 18.5 percent of tofacitinib-treated patients achieved the primary endpoint of remission at week eight, compared to 8.2 percent for the placebo group. Similar results were recorded in OCTAVE Induction 2, in which 16.6 percent of patients in the tofacitinib group were in remission at this time point, versus 3.6 percent of placebo-treated patients.
Pfizer said the key secondary endpoint of mucosal healing, denoted by a Mayo endoscopic subscore of 0 or 1, was achieved in 31.3 percent of patients in the tofacitinib group in OCTAVE Induction 1, compared with 15.6 percent in the placebo group. Similarly, in OCTAVE Induction 2, mucosal healing rates of 28.4 percent and 11.6 percent were observed in the tofacitinib and placebo groups, respectively. Pfizer added that rates of adverse events, including serious adverse events, were balanced between the treatment and placebo groups in both trials.
Meanwhile, results from the OCTAVE Sustain study, which is examining tofacitinib as maintenance therapy in adults with moderately to severely active ulcerative colitis, are expected by the end of the year. The ongoing OCTAVE Open extension trial is assessing the safety and tolerability of tofacitinib in patients who completed or exhibited treatment failure in OCTAVE Sustain, or who were non-responders in OCTAVE Induction 1 or OCTAVE Induction 2.
Tofacitinib was previously approved by the FDA in 2012 for the treatment of patients with moderately to severely active rheumatoid arthritis under the name Xeljanz. The agency declined to expand the indication for the therapy to include adults with moderate-to-severe chronic plaque psoriasis in October last year.
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